NCT02142725终止3 期
Randomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 12-weeks add-on Treatment With LT 02 vs. Placebo in Patients With Ulcerative Colitis Refractory to Standard Treatment With Mesalamine
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 468
- 试验地点
- 1
- 主要终点
- Rate of clinical remission
研究概览
简要总结
The purpose of this study is to compare two different dosing regimens of phosphatidylcholine versus placebo for the induction of remission in ulcerative colitis patients non-responsive to standard mesalamine treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of ulcerative colitis
- •Active ulcerative colitis disease extent ≥ 15 cm
- •Active disease despite treatment with mesalamine
排除标准
- •Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis, diverticular disease associated colitis,
- •Toxic megacolon or fulminant colitis
- •Colon resection
- •Evidence of infectious colitis
- •Celiac disease
- •Bleeding hemorrhoids
- •History or presence of ischemic heart disease, myocardial infarction, peripheral arterial disease, ischemic stroke, or transient ischemic attack
- •Any severe concomitant renal, endocrine, or psychiatric disorder
- •Any relevant known systemic disease
- •History of cancer in the last five years
- •Abnormal hepatic function or liver cirrhosis
- •Abnormal HbA1c at screening visit
- •Patients with known hypersensitivity to soy
- •Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP)
- •Treatment with steroids/methotrexate/Tumor necrosis factor-alpha-antagonists/azathioprine/ 6-mercaptopurine/anti-integrin/coumarins
- •Treatment with other investigational drug
- •Existing or intended pregnancy or breast-feeding
研究组 & 干预措施
LT-02
Experimental
LT-02 0.8g four times daily
干预措施: LT-02 (Drug)
B: LT-02
Experimental
LT-02 1.6g twice daily
干预措施: LT-02 (Drug)
Placebo
Placebo Comparator
LT-02 Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of clinical remission
时间窗: 12 weeks
次要结局
- Number of days with urgency per week(12 weeks)
- Number of stools per week(12 weeks)
- Physician's global assessment at final visit(12 weeks)
- Rate of patients with clinical improvement(12 weeks)
- Time to first resolution of symptoms(12 weeks)
- Rate of mucosal healing(12 weeks)
- Rate of histologic remission(12 weeks)
- Quality of life(12 weeks)
研究者
研究点 (1)
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